Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -348

Accepted - Volume 307

Comment Record
Commentor Ms. Cindi Kelleher Date/Time 2003-03-19 13:23:32
Organization Pioneer Nutritional Formulas, Inc.
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments 304 Shelburne Center Rd. Shelburne Falls, MA 01370 March 19, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket 95N-0304 Dear Sir or Madam, I work for Pioneer Nutritional Formulas, Inc., a vitamin/supplement company in Shelburne Falls, MA. We have been in business for nearly 20 years. Both our customers and we appreciate how the passage of the Dietary Supplement Health and Education Act of 1994 improved consumer access to dietary supplements and information about them, while increasing consumer protection against unsafe products and false and misleading claims. I am concerned that the FDA has only just begun to initiate aggressive enforcement actions under DSHEA, yet is calling for suggestions for increased legislative authority in order to better regulate the supplement industry. Shouldn’t you first give these recent efforts a chance to work, and perhaps even issue good manufacturing practices for supplements, before calling for new laws? Simply put, I believe the agency can regulate ephedra without dismantling DSHEA. It is also my understanding the DSHEA increased the FDA’s enforcement powers and that the FDA can seize a dietary supplement if it presents an unreasonable or significant risk of illness or injury. Furthermore, the government can stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard. The former FDA commissioner, Dr. Jane Henney, has even stated before Congress that she believes that DSHEA provides the FDA with the necessary legal authority to protect the public health. I agree with Dr. Henney, strongly support DSHEA, and do not think that any additional legislative authority is necessary. Sincerely, Cindi Kelleher

EC -348